Repair of Articular Osteochondral Defect
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Knee injury and Osteoarthritis Outcome Score
Study Overview
Brief Summary
Background: Matrix-associated autologous chondrocyte implantation (MACI) has been recently used to treat cartilage defects. The investigators had previously developed a biphasic osteochondral composite as the construct for chondrocyte implantation. The investigators further conducted this feasibility study of such device to treat patients with osteochondral lesion of the knee joints.
Detailed Description
Methods: Ten patients with symptomatic isolated osteochondritis at the femoral condyle were treated by replacing the pathological tissue with autologous chondrocyte-laden biphasic cylindrical plug of DL-poly-lactide-co-glycolide, with its lower body impregnated with -tricalcium phosphate as the osseous phase. The osteochondral lesion was drilled to fashion a pit of identical size and shape as the plug. The chondrocyte-laden plug was press-fit to fill the pit. Outcome of repair was examined by KOOS scale at 3, 6 and 12 months postoperatively, and tissue sample was collected with second-look arthroscopic needle-biopsy at 12 months. The primary outcome parameter was the postoperative change of KOOS; and the secondary outcome parameter was the regeneration of cancellous bone and hyaline cartilage at the repair site.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 18 ~ 60 years
- •Articular cartilage defect of the knee
- •Diagnosis by X-ray and/or MRI, Arthroscopy
- •Confined area: diameter < 3 cm
- •Full layer cartilage damage
Exclusion Criteria
- •Pregnancy
- •Nonunion of fracture around the knee
- •Diffuse degenerative arthropathy of the knee
- •Diffuse cartilage pathology due to
- •Rheumatism: rheumatoid, psoriatic, ...
- •Metabolic disorder: gouty, hemorrhagic, ...
- •Stiff knee from any reason
- •Flexion < 130˚
- •Extension loss > 20˚
Outcomes
Primary Outcomes
Knee injury and Osteoarthritis Outcome Score
Time Frame: 1 Year
Secondary Outcomes
No secondary outcomes reported